RecruitingNot Applicable

Knee Related Subchondral Bone Lesions Treated With IOBP

United States100 participantsStarted 2021-11-17

Plain-language summary

The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able to read, understand, sign and complete informed consent
. Male or female subject between the ages of 18-60 years
. Subject has had pain for greater than three months
. Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure
. Subject has stable ligaments
. Subject has neutral alignment (max 5° varus or valgus)
. Subject has a VAS score greater than or equal to five
. Subject is scheduled to undergo surgical intervention using IOBP®

Exclusion criteria

. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
. Subject has had lower extremity surgery within six months
. Subject has had more than two prior surgical procedures in the operative leg

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevention of additional surgery into the target knee

Timeframe: 5 years

Trial details

NCT IDNCT05314608

SponsorArthrex, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-05-17

Contact for this trial

Justin W Moss, DHSc

770 584 4972 justin.moss@arthrex.com

View on ClinicalTrials.gov More Subchondral Cyst trials